FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3211056
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08382
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 25, 2013
- Report Date
- April 30, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD BECAME DISLODGED DURING CORONARY ARTERY BYPASS SURGERY AND VALVE REPLACEMENT. THE LEAD EXHIBITED LOSS OF CAPTURE AND A DECREASE IN P-WAVE AMPLITUDE. AN X-RAY WAS DONE WHICH CONFIRMED THE LEAD DISLODGEMENT. SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309759 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| L| R | 1290| K063| 4086| 4087 |